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GLZ — Antigens, If, Toxoplasma Gondii Class II

FDA Device Classification

FDA product code GLZ covers "Antigens, If, Toxoplasma Gondii", a Class II medical device regulated under 21 CFR 866.3780. Submissions are reviewed by the Microbiology panel. At least 18 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
GLZ
Device Class
Class II
Regulation Number
866.3780
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K924882zeus scientificTOXOPLASMA IGM IFA TEST SYSTEMMarch 23, 1993
K880007gull laboratoriesTOXO IGM TESTMarch 17, 1988
K850591intl. diagnostic technologyFIAX TOXO-M ANTIBODIES TEST KITApril 30, 1985
K844287apple diagnostic productsADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDIIJanuary 7, 1985
K842664amico labANTI-TOXOPLASMA GONDII KITAugust 28, 1984
K832900bionetic laboratory productsIMMUNOENZYME TEST SYS-DETECT-IGM ANTINovember 14, 1983
K830869parasitic disease consultantsPOLYCHACO INDIRECT IMMUNOFLUORESCENCEAugust 11, 1983
K811562immuno-diagnostic productsTOXOPLASMOSIS TEST KITJuly 16, 1981
K803134microbiological researchTOXOPLASMA GONDII SEROLOGICAL REAGENTSJanuary 29, 1981
K801720litton bioneticsTOXO BIO-BEAD TITRATION KITSeptember 16, 1980
K791618litton bioneticsTORCH BIO-BEAD SCREEN KITNovember 13, 1979
K791611litton bioneticsTOXO BIO-BEAD SCREEN KITNovember 13, 1979
K791571zeus scientificTOXOPLASMA ANTIBODY TEST SYSTEMSeptember 24, 1979
K790464intl. diagnostic technologyFIAX TEST KIT FOR ANTI-TOXOPLASMA ANTIBOJune 13, 1979
K790360bio-radQUANTAZYME TOXOPLASMAMay 22, 1979
K781549microbiological assocTOXELISA TEST KITDecember 7, 1978
K780352milliporeIMMUNOZYME TOXOPLASMA ANTIBODYJune 28, 1978
K772243gull laboratoriesTOXO TESTDecember 22, 1977

FDA data resources